Incontinence treatment device

ABSTRACT

An incontinence treatment device includes a urethral support and first and second connectors. The urethral support extends between a first end and a second end and has porosity that is configured to allow tissue in-growth through the urethral support. The first connector is attached to the first end of the urethral support and the second connector is attached to the second end of the urethral support. At least one of the first connector and the second connector is a cross-linked polymer connector having a glass transition temperature between 40-70 degrees Celsius. The cross-linked polymer connector has an initial length that is elongated to an implant length that is greater than the initial length. Means for heating the cross-linked polymer connector from an extracorporeal location through intact skin is provided, thereby shortening the cross-linked polymer connector.

BACKGROUND

Devices for treating urinary incontinence include slings, supports, andother scaffold-like devices that are implanted in a patient's body tosupport the urethra.

One incontinence treatment device is a sub-urethral sling that issurgically implanted under the urethra. The implanted sling supports theurethra, which inhibits urine from leaking out of the urethraparticularly during a provocative event (e.g., coughing or sneezing).

Implanting an incontinence treatment device and anatomically securingthe device can be difficult and time-consuming. In addition, imperfectanatomical fixation or adjustment in the tension of the device relativeto the urethra has the potential to produce suboptimal results in thetreatment of urinary incontinence.

Other urinary incontinence treatment devices, such as injected bulkingliquids, provide beneficial effects, but the beneficial effects ofbulking liquids can potentially decrease over time, for example as theliquid is absorbed into the body.

Improved incontinence treatment devices and methods of implantation ofthe devices would be welcomed by both the patient and the surgicalstaff.

SUMMARY

One aspect provides an incontinence treatment device including aurethral support and first and second connectors. The urethral supportextends between a first end and a second end and has porosity that isconfigured to allow tissue in-growth through the urethral support. Thefirst connector is attached to the first end of the urethral support andthe second connector is attached to the second end of the urethralsupport. At least one of the first connector and the second connector isa cross-linked polymer connector having a glass transition temperaturebetween 40-70 degrees Celsius. The cross-linked polymer connector has aninitial length that is elongated to an implant length that is greaterthan the initial length. Means for heating the cross-linked polymerconnector from an extracorporeal location through intact skin isprovided, thereby shortening the cross-linked polymer connector.

One aspect provides a device adapted to treat incontinence in a patient.The device includes a support having a first end and a second end; afirst connector attached to the first end of the support and a secondconnector attached to the second end of the support; a first anchorcoupled to the first connector and a second anchor coupled to the secondconnector; and a ferromagnet. At least one of the connectors is across-linked polymer connector. The device is implantable such that theanchors are fixed within a pelvis of the patient and tissue is grownthrough the support. The ferromagnet is attached around eachcross-linked polymer connector between a midpoint of the cross-linkedpolymer connector and its respective anchor. The device includes meansfor shortening, through intact skin from an extracorporeal location, alength of the cross-linked polymer connector between the midpoint of thecross-linked polymer connector and its respective anchor.

One aspect provides a method of treating incontinence in a patient thatincludes implanting a support by suspending the support from a pair ofconnectors attached to tissue thereby supporting a urethra of thepatient with an implanted support and a pair of implanted connectors.The method additionally includes evaluating the patient forincontinence, and reducing the incontinence of the patient by shorteninga length of one of the pair of implanted connectors through intact skinfrom a location extracorporeal of the patient.

One aspect provides a method of treating incontinence in a patient thatincludes implanting in a healthcare setting a device having a supportsupporting a urethra of the patient, a cross-linked polymer connectorextending between the support and an anchor attached to pelvic tissue ofthe patient, and a ferromagnet attached around the cross-linked polymerconnector between a midpoint of the cross-linked polymer connector andthe anchor. The method additionally includes evaluating the patient forincontinence after discharging the patient from the healthcare setting,and reducing incontinence of the patient by applying energy throughintact skin of the patient thereby heating and shortening thecross-linked polymer connector between the midpoint of the cross-linkedpolymer connector and the anchor.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other. Likereference numerals designate corresponding similar parts.

FIG. 1A is a top view of one embodiment of an incontinence treatmentdevice including a support and connectors extending from the support.

FIG. 1B is a cross-sectional view of one of the connectors of the deviceillustrated in FIG. 1A.

FIG. 1C is a cross-sectional view of the connector of FIG. 1A includingan insulating sheath.

FIG. 2A is a perspective view of one embodiment of a process forextruding a strand suitable for use as one of the connectors illustratedin FIG. 1B.

FIG. 2B is a side view of one embodiment of a length of the strandillustrated in FIG. 2A being irradiated to cross-link molecules of thestrand.

FIG. 2C is a side view of the cross-linked strand illustrated in FIG. 2Bstretched to orient the molecules in the cross-linked strand and providethe strand at an appropriate implant length.

FIG. 2D is a side view of the stretched strand illustrated in FIG. 2Cheated to relax the oriented molecules in the cross-linked strand andshrink the strand from the implant length to a shorter length.

FIG. 3A is a schematic view of the incontinence treatment deviceillustrated in FIG. 1A implanted in a patient.

FIG. 3B is a schematic view of the implanted incontinence treatmentdevice adjusted from an extracorporeal location through intact skin ofthe patient.

FIG. 4 is a perspective view of one embodiment of an incontinencetreatment device including a ferromagnet placed around a heat-shrinkableconnector.

FIG. 5A is a perspective view, FIG. 5B is an axial cross-sectional view,and FIG. 5C is a longitudinal cross-sectional view of the ferromagnetillustrated in FIG. 4.

FIG. 6A is a schematic view of the incontinence treatment deviceillustrated in FIG. 4 implanted in a patient.

FIG. 6B is a schematic view of the incontinence treatment deviceillustrated in FIG. 6A adjusted from an extracorporeal location throughintact skin of the patient.

FIG. 7 is a top view of one embodiment of an incontinence treatmentdevice including a pair of trans obturator arms, each provided with aconnector and a ferromagnet, and a pair of suprapubic arms.

FIG. 8 is a schematic view of the incontinence treatment deviceillustrated in FIG. 7 implanted in a patient.

FIG. 9 is a flow diagram of one embodiment of a method of treatingincontinence in a patient.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

Tissue includes soft tissue, which includes dermal tissue, sub-dermaltissue, ligaments, tendons, or membranes. As employed in thisspecification, the term “tissue” does not include bone.

In this application, skin is defined to be an organ including anepidermis upper layer, a hypodermis lower layer, and a dermis layerbetween the epidermis and hypodermis layers. Intact skin means skin inwhich the dermis layer is not compromised, which includes, as twoillustrative examples, a dermis layer that has been incise but hashealed post-surgically and a naturally occurring dermis layer that hasnot been incised in a surgical procedure.

In this application, “extracorporeal” means from outside of the body.The expression of acting on an implant from “an extracorporeal locationthrough intact skin” means that the implant is adjusted from outside thepatient without surgically accessing the implant or cutting into theskin.

People who are incontinent may be segregated into two groups: those withhyper-mobile urethras and those whose urethras are not hyper-mobile. Ahyper-mobile urethra will translate into alignment with an exit of thebladder, thus creating a “straight-shot” pathway from the bladder thatallows urine to escape from the bladder and out of the urethra.Physicians have developed an evaluation to determine if the patient hasa hyper-mobile urethra. The evaluation entails the placement of anindicator stick into the longitudinal axis of the urethra such that aportion of the indicator stick extends distally out of the patient'sbody (those of skill in the art refer to the evaluation as the “Q-tip™test”). The patient is prompted to initiate a provocative event, forexample a cough or a tightening of the abdominal muscles, and thephysician observes the indicator stick for movement (this evaluation issometimes referred to as the “cough test”). Movement of the indicatorstick indicates that the longitudinal axis of the urethra is moving,which is indicative of the patient having a hyper-mobile urethra.

The urethra is normally supported by connective and other tissues. Overtime, and particularly with parous women, the support of the urethraerodes, giving rise to hyper-mobility of the urethra. As describedabove, hyper-mobile urethras are susceptible to the undesirable leakingof urine during provocative events such as sneezing, laughing, orcoughing (which is sometimes referred to as stress urinaryincontinence).

The implant described herein supports the urethra to treat incontinence.In addition, the implant described herein is adjustable post-implantwithout surgically accessing the implant (e.g., from outside of thepatient's body) to modify/increase the support provided to the urethrafrom the implant over time.

FIG. 1A is a top view of one embodiment of an incontinence treatmentdevice 20 including a urethral support 22 and a pair of connectors 24,26. In one embodiment, the urethral support 22 extends between a firstend 34 and a second end 36, and the first connector 24 is connected tothe first end 34 and a second connector 26 is connected to the secondend 36 of the urethral support 22.

The urethral support 22 is selected to be tissue compatible forimplantation into a human body and is configured to allow tissueingrowth through its structure to anchor the support 22 in the bodyafter implantation and healing. Suitable material for the support 22includes autograft material (the patient's own tissue), allograftmaterial (tissue from a cadaver), xenograft material (tissue fromanother species), or synthetic materials such as woven fabrics, meshes,nonwoven fabrics, meshes, fibrillated fibers, or spun and fibrillatedfibers that are provided with voids (pores) configured to allow tissueingrowth into the support. The pores are generally larger, on average,than 75 μm.

The support 22 is suitably shaped as a rectangular sling, a multi-armsupport having an X-shape with four arms extending from a body, aT-shaped sling having two transverse arms and one longitudinal body, orother pelvic support shapes.

In one embodiment, the support 22 is a knitted monofilamentpolypropylene mesh having a mass per area between approximately 15-35g/m² with a pore size between approximately 500-1500 μm and a thicknessof approximately 260 μm. This mesh is thin and light weight (i.e., thebasis weight is less than approximately 35 g/m²) to provide a thin andcomfortable mesh that is less likely to erode tissue that contacts themesh and less likely to be sensed through the tissue layers by thepatient. Other suitable materials for the support 22 include fabricsformed from polyester, polyethylene, silicone, urethanes, polyurethanes,copolymers, or block copolymers of these or suitably similar polymericmaterials. Suitable such knitted monofilament polypropylene mesh isavailable from Coloplast Corp., Minneapolis, Minn. Other suitable wovenpolypropylene mesh material is available from, for example, HerniaMesh,Chivasso, Italy.

The connectors 24, 26 are provided as strands that are employed tosuspend the urethral support 22 in a patient's body to support theurethra (female) or to elevate and compress the urethra (male). In oneembodiment, at least one of the connectors 24, 26 is provided as across-linked polymer connector having a glass transition temperaturebetween 40-70° C. The cross-linked polymer connector, for exampleconnector 26, is provided as an amorphous polymer that is initiallyirradiated to cause internal cross-linking of the polymer molecules. Thecross-linking sets the molecules in a preferred orientation. Thecross-linked polymer connector 26 is stretched from an initial length toa stretched, final product length. When the stretched cross-linkedpolymer connector is heated, or energy is otherwise provided to overcomethe stretched orientation of the molecules, the molecules relax andreturn to the cross-linked, preferred orientation associated with theinitial length of the cross-linked connector 26. In this manner, thecross-linked polymer connector 26 is heat-shrinkable between itsstretched, final product length and its initial length.

FIG. 1B is a cross-sectional view of the cross-linked polymer connector26. In one embodiment, the cross-linked polymer connector 26 includes anamorphous polymer 40 that is cross-linked and metal particles 42 thatare doped or otherwise dispersed into the polymer 40. The metalparticles 42 can be heated, and when heated, cause the polymer 40 to beheated above its glass transition temperature to allow the orientedmolecules relax to their initial cross-linked state. In one embodiment,the metal particles 42 are ferromagnetic and respond to inductionheating, for example as provided by an inductive heat source producingan alternating current field.

Suitable amorphous polymers 40 that are configured for cross-linkinginclude nylon 12, high density polyethylene, and polyester, as threeexamples. In one example, an amorphous nylon 12 polymer is selectedhaving a glass transition temperature between 40-70° C. The nylon 12 isirradiated with an electron beam source to cross-link the molecules ofthe nylon 12. The nylon 12 is stretched and the cross-linked moleculesare stretched and oriented. At temperatures below 40° C., the nylon 12is stable to local temperatures (the temperature of a healthy human bodyis approximately 37° C.). For temperatures above 40° C., approaching 70°C., the nylon 12 has sufficient molecular mobility to allow the orientedmolecules to move or relax from the stretched and oriented state back tothe initial cross-linked orientation, thus shrinking in length whenheated.

In one embodiment, the metal particles 42 are provided in the polymer40. The metal particles 42 are configured to be heated and conduct theheat to the polymer 40 to transition the polymer 40 between thestretched/oriented state back to the initial cross-linked (short) state.Suitable materials for the metal particles 42 include metal elements andalloys of metal, for example iron, or an iron alloy including NiCu, oran iron alloy including CoPd.

The metal particles 42 are provided to conduct heat to the polymer 40.FIG. 1C illustrates an embodiment where the cross-linked polymerconnector 26 is co-axially extruded, for example, or otherwise coated toinclude a co-axial sheath 43 of a low thermal conductivity materialprovided to insulate the cross-linked polymer connector 26, when heated,from adjacent tissue. Suitable materials having low thermal conductivityinclude foams (for example polyolefin foam) or polymer sheaths that arenot doped with metal particles. Thus, in one embodiment the illustratedcross-linked polymer connector 26 is provided with an insulatingexterior cover/sheath 43 of a material having a thermal conductivitythat is lower than the thermal conductivity of the polymer 40/particle42 system.

FIG. 2A is a perspective view of one embodiment of a process 50 forforming a strand 51 suitable for use as one of the cross-linked polymerconnectors 26. In one embodiment, the strand 51 is formed by an extruder53 that delivers amorphous polymer through a fiber-forming spinnerette52.

FIG. 2B is a side view of one embodiment of the strand 51 beingirradiated by an irradiation source 54 to cross-link molecules of thestrand 51. The radiation causes the strand 51 to retain a memory of itsinitial length L1.

FIG. 2C is a side view of the strand 51 stretched to a stretched implantlength Ls to form the cross-linked connector 26. The energy or the forcethat is employed to stretch the cross-linked connector 26 from itsinitial length L1 to the stretched length Ls (e.g., the implant lengthLs) overcomes the energy of the cross-linked molecular orientation toorient (or re-orient) the molecules in the connector 26 at the desiredimplant length Ls.

FIG. 2D is a side view of the stretched strand/connector 26 heated torelax the oriented molecules in the cross-linked strand/connector 26.When the connector 26 is heated, from a heat source or energy source 56such as an inductive energy source, the molecules relax and theconnector 26 shrinks to a shortened length L2 (shorter than the implantlength Ls). Additional applied energy or continuous heating will shrinkthe connector 26 back to the cross-linked orientation associated withthe un-stretched, initial length L1 (FIG. 2B). Suitable energy sources56 are those that are able to penetrate the human body through intactskin and include microwave energy sources or inductively coupled devicesthat provide an alternating current filed that couples with the metalparticles 42 (FIG. 1B) to heat the metal particles 42, thus heating andshrinking polymer 40.

As mentioned above, in one embodiment the connector 26 is fabricatedfrom an amorphous polymer 40 that is doped with metal particles 42. Theabove discussion applies to connectors or strands formed from across-linkable amorphous polymer, such as nylon 12 that does not includemetal particles. An un-doped cross-linked polymer system, whenirradiated, stretched, and suitably heated (e.g., via radiation orconvection), will behave as described above. In one embodiment, themetal particles 42 are incorporated into the amorphous polymer 40 toallow the connector 26 to receive extracorporeal heat sources such asmicrowaves, inductors, and other wireless energy transmitters and becomeheated.

FIG. 3A is a schematic view of the incontinence treatment device 20attached to tissue to support a urethra U of the patient. In oneembodiment, the device 20 is attached between opposing obturatormembrane tissue OT of opposing obturator foramen OF, although the deviceis acceptably attachable to other pelvic tissue. The urethral support 22is generally placed against bulbous spongiosum tissue B of the urethrato decrease possible erosion of the urethra itself. The connectors 24,26 extend from the support 22 around a portion of the pubic ramus PRbones and are terminated in the obturator membrane tissue OT. In oneembodiment, the patient is a female and the incontinence treatmentdevice 20 supports the urethra U without compressing the urethra U. Inone embodiment, the patient is a male and the incontinence treatmentdevice 20 supports the urethra U by elevating and compressing at least aportion of a bulb the urethra U.

In one embodiment, the incontinence treatment device 20 is introducedthrough a single perineal incision 60 along an inside out pass thatplaces the connectors 24, 26 around a portion of the pubic ramus PR. Forexample, the surgeon places the connectors 24, 26 either digitally witha finger or with a tool into the incision 60 and guides the eachconnector 24, 26 inwardly for termination with pelvic tissue, forexample a ligament or the membrane tissue OT of the obturator foramenOF.

The incontinence treatment device 20 is implanted in the patient suchthat the support 22 is suspended under the urethra U in contact with thebulbous spongiosum tissue B, and the connectors 24, 26 are terminatedinto tissue. When implanted, the connector 26 extends between thesupport 22 and the membrane tissue OT and has the stretched implantlength Ls. The device 20 is initially adjusted during the implantationsurgery to ensure that an appropriate level of support is provided tothe urethra U to reduce or eliminate the incontinent condition of thepatient. Thereafter, the surgeon closes the minimally invasive incision60 according to acceptable practices. The incontinence treatment device20 provides the patient with a level of continence immediately afterimplantation due to the suspension provided by the support 22 to theurethra, or due to the elevation and compression (in males) that isprovided to the urethra U.

FIG. 3B is a schematic view of the implanted incontinence treatmentdevice 20. The patient, through the healing process or other activities,might eventually experience a reduced level of continence characterizedby leaking of urine from the urethra. The prior solution, in such cases,would be to schedule the patient for surgery, incise tissue of thepatient, and adjust the tension of the support or the connectorsmanually inside of the body. In contrast, the implanted incontinencetreatment device 20 provides the patient and the surgeon with theability to adjust the connector 26 from an extracorporeal locationthrough intact skin S by shortening the cross-linked polymer connector26 from the implanted length Ls (FIG. 3A) to a shorter length L2. Theshortened connector 26 “tightens” and applies increased beneficialsupport to urethra U to reduce or eliminate the patient's incontinence.

In one embodiment, the surgeon adjusts the connector 26 in a clinicalsetting by applying an extracorporeal energy source, for example aninductive heating device providing alternating current energy throughthe patient's skin S, without forming an incision, and the energy isdirected to the connector 26. The metal particles 42 (FIG. 1B) areinductively heated and cause local heating of the polymer 40. Heating ofthe polymer 40 relaxes the orientation of the molecules of the connector26 and allows the molecules to return toward the initial orientationassociated with the cross-linked state having initial length L1 (FIG.2B). In this manner, the connector 26 heat shrinks from the finalstretched implant length Ls (FIG. 3A) to a shorter length L2 (FIG. 2D).The shorter length L2 is less than the stretched implant length Ls, suchthat the connector 26 shrinks in response to local heating to provideadditional urethral support and improved continence. If the energysource is applied for a sufficiently long duration of time, theconnector 26 will heat shrink from the final product length, orstretched implant length Ls, all the way back to the initial length L1.

FIG. 4 is a perspective view of one embodiment of an incontinencetreatment device 80. The device 80 includes a support 82, connectors 84,86 extending from the support 82, anchors 88, 90 attached to theconnectors 84, 86, respectively, and a ferromagnetic unit 92 attached tothe connector 86.

The support 82 is similar to and suitably fabricated from the materialsdescribed above for support 22.

In one embodiment, at least one of the connectors 84, 86 is fabricatedto provide a cross-linked polymer connector having a glass transitiontemperature between 40-70° C. In one embodiment, the first connector 84is provided as a standard polypropylene suture material and the secondconnector 86 is provided as a heat shrinkable cross-linked polymerconnector as described above for connector 26.

In one embodiment, the anchors 88, 90 are adjustable anchors that moverelative to the connectors 84, 86, respectively. In one embodiment, atleast one of the anchors 88, 90 is fixed relative to its respectiveconnector 84, 86.

The ferromagnetic unit 92 is provided to receive energy and be heated,and conduct the heat to the connector 86, which allows the connector 86to heat shrink as the molecules in a cross-linked polymer connector 86relax in response to the heat energy. For example, in one embodimentenergy is delivered to the patient's body from an extracorporeallocation from an induction heating device. The ferromagnetic unit 92couples with the field from the induction heating device and becomesheated. The heated ferromagnetic unit 92 conducts heat to the connector86, allowing the connector 86 to be heated to a temperature above itsglass transition temperature, which relaxes the molecules in theconnector 86 to permit heat shrinking of the connector 86.

The heat delivered to the connector 86 is proportional to the length ofthe ferromagnetic unit 92. It has been discovered that the amount ofshrinkage delivered to the connector 86 is a function of the length ofthe ferromagnetic unit 92. With this in mind, in one embodiment theferromagnetic unit 92 is placed around less than half of the implantlength Ls of the connector 86. In one embodiment, the ferromagnetic unit92 is placed around the connector 86 closer to the second anchor 90 thanto the support 82. That is to say, in one embodiment the ferromagneticunit 92 is placed on the connector 86 between a midpoint Mp of theconnector 86 and the anchor 90 to heat and shorten that portion of theconnector 86. In one embodiment, the ferromagnetic unit 92 has a lengthbetween 0.5-6.0 cm, and preferably the ferromagnetic unit 92 has alength of approximately 2 cm.

In one embodiment, the ferromagnetic unit 92 is placed on the connector86 between a midpoint Mp of the connector 86 and the anchor 90 to heatand shorten that portion of the connector 86 and not heat the length ofthe cross-linked polymer connector 86 between the midpoint Mp of theconnector 86 and the support 82.

FIG. 5A is a perspective view, FIG. 5B is an axial cross-sectional view,and FIG. 5C is a longitudinal cross-sectional view of the ferromagnetunit 92. In one embodiment, the ferromagnetic unit 92 is provided as acylinder having an axial hole 94 extending the length of the cylinder.The axial hole 94 is sized to receive and fit snuggly around theconnector 86 in a heat-conducting configuration.

In one embodiment, the ferromagnetic unit 92 includes a core 96 ofmaterial and a thermal insulator 98. The core 96 of material isconfigured to respond to induction heating, and in one embodiment isprovided as an alloy of NiCu or an alloy of CoPd. The ferromagnetic unit92 is heatable to heat the connector 86, and is preferably tailored tominimize overheating and/or heating of the adjacent tissue. For example,in one embodiment the core 96 is selected to have a Curie temperaturethat is higher than the glass transition temperature of the connector86. In this configuration, the ferromagnetic unit 92 would cease to heatonce it becomes paramagnetic as it reaches its Curie temperature. Inthis manner, the ferromagnetic unit 92 is self-regulating and isdesigned to have a ceiling temperature above which it will not heat. Forexample, in one embodiment the connector 86 has a glass transitiontemperature of between 40-70° C. and the ferromagnetic unit 92 isfabricated to have a Curie temperature of between 60-75° C. As anexample, in one embodiment the cross-linked polymer connector 86 is heatshrinkable at a temperature above 43 degrees Celsius, and theferromagnetic unit 92 has a Curie temperature of approximately 60degrees Celsius such that the ferromagnetic unit 92 will inductivelyheat to a temperature of 60 degrees Celsius or less to effectively heatthe connector 86 without undesirably over heating the surroundingtissue.

The thermal insulator 98 is provided around the core 96 to ensure thatthe temperature of the ferromagnetic unit 92 does not become so hot asto deleteriously affect the patient. In one embodiment, the thermalinsulator 98 is provided as a ceramic or a pyrolytic carbon sleevedisposed around an exterior surface of the core 96.

FIG. 6A is a schematic view of the incontinence treatment device 80implanted in a patient. The anchors 88, 90 are fixed into tissue T andthe connectors 84, 86 extend to the support 82 to suspend it under theurethra in contact with the bulbous spongiosum B tissue. Theferromagnetic unit 92 is closer to the second anchor 90 than it is tothe support 82 such that a distance D1 is established between an end ofthe support 82 and the tissue T. In one embodiment, the incontinencetreatment device 80 is implanted through a minimally invasive incisionand suspended between the membranes of the opposing obturator foramen ofthe patient.

The device 80 is adjusted by the surgeon during surgery to ensure thatan appropriate level of support is provided to the urethra U to reduceor eliminate the incontinent condition of the patient. Thereafter, thesurgeon closes the minimally invasive incision according to acceptablepractices. The incontinence treatment device 80 provides the patientwith a level of continence immediately after implantation due to thesuspension provided by the support 82 to the urethra, or due to theelevation and compression (in males) that is provided to the urethra U.

The implanted incontinence treatment device 80 provides the surgeon withthe ability to adjust the connector 86 from an extracorporeal locationthrough intact skin of the patient, thereby shortening the cross-linkedpolymer connector 86 and applying increased beneficial support tourethra U.

FIG. 6B is a schematic view of the incontinence treatment device 80 asimplanted and adjusted from an extracorporeal location through intactskin of the patient. There can be times when the patient discovers thepresence of stress urinary incontinence, and the device 80 is configuredto treat the stress urinary incontinence in a clinical setting. In oneapproach, the patient meets with the surgeon to discuss theincontinence, and the surgeon evaluates the level of incontinence, forexample with the “cough test” described above. If the surgeon determinesthat stress urinary incontinence is present, the connector 86 isshortened from a location extracorporeal from the patient, without anincision, to reduce or eliminate the stress urinary incontinence.

In one embodiment, the surgeon applies an energy field through theintact skin of the patient, and the energy heats the ferromagnetic unit92. The heated ferromagnetic unit 92 transfers heat to the connector 86,which warms a portion of the connector 86 above the glass transitiontemperature of the cross-linked polymer connector 86, thus allowing themolecules of the connector 86 to relax and shrink the connector 86 fromthe distance D1 (FIG. 6A) to distance D2.

Small changes in the length of the connector 86 will result in increasedsupport to urethra U. In this regard, the length of the connector 86need not be adjusted from the stretched implant length Ls all the wayback to the much shorter initial length L1. The surgeon, as guided byexperience, will briefly apply the energy to the connector 86, repeatthe cough test, and iterate this process until a suitable level ofcontinence for the patient is achieved.

In one embodiment, the ferromagnetic unit 92 has a length between 0.5-4cm and is inductively heatable through intact skin to heat and therebyshorten only that portion of the connector 86 that is under theferromagnetic unit 92 and that portion of the connector 86 that iswithin one length of the ferromagnetic unit 92.

FIG. 7 is a top view of one embodiment of an incontinence treatmentdevice 100. The device 100 includes a support body 102, a pair of transobturator arms 104, 106 extending from the support body 102, a pair ofsuprapubic arms 108, 110 extending from the support body 102 andconnectors 114, 116, 118, 120 each extending from a respective one ofthe arms. The support body 102 and the arms 104, 106, 108, 110 are eachsuitably fabricated from the materials described above for the support22 (FIG. 1A).

In one embodiment, the connectors 114, 116 are provided with anchors124, 126, respectively. The anchors 124, 126 include anchors that arefixed to the respective connectors, anchors that are movable relative totheir connectors, or combinations of fixed and adjustable anchors.

One or more of the connectors 114, 116, 118, 120 is configured to beheat shrinkable consistent with the embodiment described above in FIG.1A including the cross-linked polymer that is doped with metal particlesor the embodiment described above in FIG. 4 including the cross-linkedpolymer provided with a ferromagnet. For example, in one embodiment theconnectors 114, 116 are each provided as a cross-linked polymerconnector have a glass transition temperature between 40-70° C. andinclude a ferromagnetic unit 134, 136, connected around a respective oneof the connectors 114, 116. In another embodiment, all of the connectors114, 116, 118, 120 are provided as heat shrinkable connectors(anchorless or with anchors as determined to be suitable for thesurgical application).

In one embodiment, the incontinence treatment device 100 is surgicallyimplanted into a patient via a single, minimally invasive incision inwhich the anchors 124, 126 are attached to a membrane extending over anopposing one of the obturator foramen to suspend the trans obturatorarms 104, 106 across the pelvis, and the suprapubic arms 108, 110 aretunneled and terminated subcutaneously within the patientsuprapubically. In one embodiment, the suprapubic arms 108, 110 areprovided with optional removable sleeves 138, 140, respectively, thatare employed to assist in the placement of the suprapubic arms 108, 110suprapubically. The sleeves 138, 140 are removed from the arms 108, 110after the arms are placed suprapubically within a patient.

FIG. 8 is a schematic view of the incontinence treatment device 100implanted in a male patient. The illustration presents a sub-dermal viewof the location of the support body 102 relative to the ventral urethralbulb B of the patient. The trans obturator arms 104, 106 extend betweenmembranes covering the obturator foramen OF. The suprapubic arms 108,110 are tunneled and terminated subcutaneously within the patientsuprapubically.

The tension in the connectors 114, 116 is adjustable surgically via theanchors 124, 126 that tension the support body 102 to elevate andcompress the ventral urethral bulb B of the patient. The suprapubic arms108, 110 are tunneled subcutaneously to compress the perineal urethra U.The surgeon adjusts the tension/elevation of the support body 102 viathe anchors 124, 126, and adjusts the compression of the support body102 against the ventral urethral bulb B of the patient by selectivelytightening the suprapubic arms 108, 110. This surgical adjustment of thetwo pairs of arms may be done incrementally until the surgeon achievesthe desired coaptation of the urethra U through the elevation andcompression of the ventral urethral bulb B of the patient.

Thereafter, the tension in the connectors 114, 116 is adjustablepost-operatively through the intact skin of the patient (without formingan incision) to address instances of recurring incontinencepost-surgically consistent with the embodiments described above.

FIG. 9 is a flow diagram 150 of one embodiment of a method of treatingincontinence in a patient. The method includes implanting the device at152 and adjusting one or more connectors of the device during surgery at154. Consistent with the surgical implantation of a medical device, thepatient is discharged from a hospital or day care surgery center andallowed to heal at 156. The patient, for various reasons, may experiencethe recurrence of undesirable discharge of urine from the urethra(incontinence). The method provides means for addressing postsurgicalincontinence by evaluation of the continence of the patient at 158 by amedical professional, for example through conducting a cough test orother suitable test. One example of the cough test includes anindicator, such as an absorbent stick, placed in the patient's urethraprior to the patient being prompted to cough or otherwise voluntarilystress the abdominal area. The indicator is observed for movement (whichindicates hypermobility of the urethra) and 40 urine discharge from theurethra. If the medical professional determines that the patient doesnot have a hypermobile urethra or urine discharge, the patient is deemedto be continent at 160. Alternatively, urine discharged from the urethraindicates incontinence at 162. Embodiments described herein provide forthe adjustment of a connector or of the support of the urinaryincontinence device at 164 from an extracorporeal location as appliedthrough intact skin in an office setting to adjust/elevate/compress orotherwise provide improved support to the urethra.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present invention. This application isintended to cover any adaptations or variations of medical devices asdiscussed herein. Therefore, it is intended that this invention belimited only by the claims and the equivalents thereof.

What is claimed is:
 1. An incontinence treatment device comprising: aurethral support extending between a first end and a second end andhaving porosity configured to allow tissue in-growth through theurethral support; a first connector attached to the first end of theurethral support and a second connector attached to the second end ofthe urethral support, at least one of the first connector and the secondconnector comprising a cross-linked polymer connector having a glasstransition temperature between 40-70 degrees Celsius, the cross-linkedpolymer connector having an initial length, the cross-linked polymerconnector elongated to an implant length that is greater than theinitial length; and a ferromagnetic unit placed around less than half ofthe implant length of the cross-linked polymer connector, theferromagnetic unit inductively heatable through intact skin to heat tothereby shorten a portion of the cross-linked polymer connector.
 2. Theincontinence treatment device of claim 1, wherein the cross-linkedpolymer connector is heat shrinkable at a temperature above 40 degreesCelsius, and the ferromagnetic unit comprises a Curie temperature ofapproximately 60 degrees Celsius.
 3. The incontinence treatment deviceof claim 1, wherein the ferromagnetic unit comprises a cylinder definingan axial hole that is sized to receive the connector.
 4. Theincontinence treatment device of claim 1, wherein the ferromagnetic unithas an outer surface insulator provided to minimize heating of tissuethat is adjacent to the cross-linked polymer connector.
 5. Theincontinence treatment device of claim 1, further comprising: a firstanchor coupled to the first connector and a second anchor coupled to thesecond connector.
 6. The incontinence treatment device of claim 5,wherein the ferromagnetic unit is placed around the second connectornearer to the second anchor than to the urethral support.
 7. Theincontinence treatment device of claim 5, wherein the ferromagnetic unitis placed around the second connector between a midpoint of the secondconnector and the second anchor.
 8. The incontinence treatment device ofclaim 5, wherein the first and second anchors each comprise anadjustable anchor that is movably attached along a respective one of thefirst and second connectors.
 9. The incontinence treatment device ofclaim 5, wherein the first anchor is fixed in place relative to thefirst connector and the second anchor is an adjustable anchor that ismovably attached along the second connector.
 10. The incontinencetreatment device of claim 5, wherein the first anchor is fixed in placerelative to the first connector and the second anchor is fixed in placerelative to the second connector, and the ferromagnetic unit is disposedaround the first connector at a location nearer to the first anchor thanto the urethral support.
 11. The incontinence treatment device of claim1, wherein the ferromagnetic unit has a length and is inductivelyheatable through intact skin to heat and thereby shorten only thatportion of the connector that is under the ferromagnetic unit and thatportion of the connector that is within one length of the ferromagneticunit.
 12. A device adapted to treat incontinence in a patient, thedevice comprising: a support having a first end and a second end; afirst connector attached to the first end of the support and a secondconnector attached to the second end of the support, at least one of theconnectors comprising a cross-linked polymer connector; a first anchorcoupled to the first connector and a second anchor coupled to the secondconnector, the device implantable such that the anchors are fixed withina pelvis of the patient and tissue is grown through the support; aferromagnet attached around each said cross-linked polymer connectorbetween a midpoint of said cross-linked polymer connector and itsrespective anchor; and means for shortening, through intact skin from anextracorporeal location, a length of said cross-linked polymer connectorbetween the midpoint of said cross-linked polymer connector and itsrespective anchor.
 13. The device of claim 12, wherein the means forshortening, through intact skin from an extracorporeal location,comprises means for shortening, through intact skin from anextracorporeal location, only the length of said cross-linked polymerconnector between the midpoint of said cross-linked polymer connectorand its respective anchor.
 14. The device of claim 12, comprisingheating, through intact skin from an extracorporeal location, the lengthof said cross-linked polymer connector between the midpoint of saidcross-linked polymer connector and its respective anchor and not heatinga length of said cross-linked polymer connector between the midpoint ofsaid cross-linked polymer connector and the support.
 15. The device ofclaim 12, comprising selectively shortening only that portion of saidcross-linked polymer connector that is between the midpoint of saidcross-linked polymer connector and its respective anchor.